Aromatase inhibitors are drugs used in postmenopausal women to treat breast cancers that are fueled by estrogen. They interfere with the production of estrogen in the body. However, in some women, the breast cancer stops responding to these drugs. Exemestane is an example of an aromatase inhibitor.

In this study, researchers want to find the highest dose of an investigationaldrug called LEE011 that can be given safely with exemestane and with another drug, everolimus, in postmenopausal women with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancers that continue to grow despite aromatase inhibitor therapy.

Everolimus is a drug used in combination with exemestane. It works by blocking the activity of a molecule called mTOR, which helps cancer cells grow. LEE011 blocks a protein called CDK, which tells cancer cells to divide. Researchers hope LEE011 will slow the growth of cancer cells and lead to their death.

Patients in this study will receive LEE011 with exemestane and everolimus, or LEE011 with exemestane alone. All three drugs are taken orally (by mouth).

Patients may not have received more than one prior regimen of chemotherapy for advanced breast cancer

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Shanu Modi at 646-888-5243.

aromatase inhibitor (uh-ROH-muh-tays in-HIH-bih-ter)

A drug that prevents the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy for postmenopausal women who have hormone-dependent breast cancer.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

breast (brest)

Glandular organ located on the chest. The breast is made up of connective tissue, fat, and breast tissue that contains the glands that can make milk. Also called mammary gland.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

breast cancer (brest KAN-ser)

Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

cancer (KAN-ser)

A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

chemotherapy (KEE-moh-THAYR-uh-pee)

Treatment with drugs that kill cancer cells.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

dose (dose)

The amount of medicine taken, or radiation given, at one time.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

drug (drug)

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

estrogen (ES-truh-jin)

A type of hormone made by the body that helps develop and maintain female sex characteristics and the growth of long bones. Estrogens can also be made in the laboratory. They may be used as a type of birth control and to treat symptoms of menopause, menstrual disorders, osteoporosis, and other conditions.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

everolimus (eh-veh-ROH-lih-mus)

A drug used to treat certain types of pancreatic cancer. It is also used to treat a type of advanced kidney cancer and to treat subependymal giant cell astrocytoma in some patients. It is being studied in the treatment of other types of cancer and other conditions. Everolimus stops cancer cells from dividing and may prevent the growth of new blood vessels that tumors need to grow. It also lowers the body’s immune response. It is a type of kinase inhibitor, a type of angiogenesis inhibitor, and a type of immunosuppressant. Also called Afinitor and RAD001.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

exemestane (EK-seh-MEH-stayn)

A drug used to treat advanced breast cancer and to prevent recurrent breast cancer in postmenopausal women who have already been treated with tamoxifen. It is also being studied in the treatment of other types of cancer. Exemestane causes a decrease in the amount of estrogen made by the body. It is a type of aromatase inhibitor. Also called Aromasin.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

investigational (in-VES-tih-GAY-shuh-nul)

In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

metastatic (meh-tuh-STA-tik)

Having to do with metastasis, which is the spread of cancer from the primary site (place where it started) to other places in the body.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

molecule (MAH-leh-kyool)

The smallest particle of a substance that has all of the physical and chemical properties of that substance. Molecules are made up of one or more atoms. If they contain more than one atom, the atoms can be the same (an oxygen molecule has two oxygen atoms) or different (a water molecule has two hydrogen atoms and one oxygen atom). Biological molecules, such as proteins and DNA, can be made up of many thousands of atoms.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

mTOR

A protein that helps control several cell functions, including cell division and survival, and binds to rapamycin and other drugs. mTOR may be more active in some types of cancer cells than it is in normal cells. Blocking mTOR may cause the cancer cells to die. It is a type of serine/threonine protein kinase. Also called mammalian target of rapamycin.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

postmenopausal (post-MEH-nuh-PAW-zul)

Having to do with the time after menopause. Menopause (“change of life”) is the time in a woman's life when menstrual periods stop permanently.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

protein (PROH-teen)

A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

receptor (reh-SEP-ter)

A molecule inside or on the surface of a cell that binds to a specific substance and causes a specific physiologic effect in the cell.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

regimen (REH-jih-men)

A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

therapy (THAYR-uh-pee)

Treatment.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

will (wil)

A legal document in which a person states what is to be done with his or her property after death, who is to carry out the terms of the will, and who is to care for any minor children.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)